Clinical trial · Interventional
Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer
NCT03405168CI-TRIAL-00035825completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Antibiotic | — | UNRESOLVED | — |
| Stable Disease With a Trend of Progression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moxifloxacin Hydrochloride 400mg Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- routine therapy plus moxifloxacin
- description
- Routine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice.
- interventionNames
- Drug: Moxifloxacin Hydrochloride 400mg Tablet
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
- 1years
- description
- the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause
Secondary outcomes (3)
- measure
- objective response rate (ORR)
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female ≥ 18 years, ≤70 years. * Has measurable metastatic MBC, with at least 1 measurable lesion per RECIST criteria. * Fail first-line or above anti-tumor treatment * Evaluation is stable disease with a trend of progression. * Minimum life expectancy 16 weeks * Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis * ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks * Normal organ function. * Has signed a Patient Informed Consent Form Exclusion Criteria: * Hypersensitivity to moxifloxacin or other quinolones. * Tendon damage,peripheral neuropathy,myasthenia gravis. * Rapidly progressive visceral disease not suitable for further therapy. * Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV * With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment * Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent * Inability or unwillingness to comply with study procedures, including inability to take regular oral medication * Researchers consider it is not suitable for participation.
References
Publications (1)
- DERIVEDWang X, Li J, Shi W, Huang Z, Xia W, Huang J, Su Y, Wang S, Shi Y, Bi X, Yuan Z. Efficacy of Moxifloxacin plus Treatment of Physician's Choice in Patients with Metastatic Breast Cancer. Oncologist. 2020 Oct;25(10):e1439-e1445. doi: 10.1634/theoncologist.2020-0364. Epub 2020 Jun 1. PMID 32390277